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12374en
- Contract
- English, German
- Mid-Senior level
- Digital & Technology
- Zug
- Healthcare & Life Sciences
Skills
Quality Assurance, Deviation Management, Data Management, GxP, GMP, MS Office, Tableau, Medical Technology
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This vacancy has now expired
About our client:
On behalf of our client, a global leader within the Pharmaceutical Industry, Swisslinx is currently looking for a Quality Engineer to join a one year contract with a possible extension in Zug-area.
Your responsibilities:
- Create, update, review and training of specification documents, instructions and reports as well as technical review of validation and qualification documents
- Processing and technical review of deviations as well as technical approval of the assigned products
- Support quality management and ensure that regulated activities are carried out efficiently, effectively and in accordance
- Support in troubleshooting the assigned analysis system in the event of complex deviation reports
- Identification and presentation of improvement measures and implementation in consultation with the product team
- Interface between R&D, assembly, system testing and QA in order to find constructive solutions in the event of deviations and achieve a smooth approval
- Develop and maintain quality standards and metrics for key activities
- Mainly responsible for the deviation management of one or more products
- Responsible for the evaluation and analysis of quality data (e.g. right first time, deviation reports) as well as the management of corresponding meetings in the product team
Your background:
- Technical education with at least 2 years of professional experience in the medical technology field
- In-depth IT knowledge and understanding of complex hardware and software architectures (MS Office, Tableau)
- Experience in the regulated GxP environment, ideally medical technology (ISO 13485, GMP, FDA 21 CFR 820) in the area of ??deviation management
- Experience in deviation management of at least 2 years
- Mother tongue German or a comparable level (no exceptions)
- Fluent written English skills
Nice to haves:
- You have a pronounced quality awareness and a structured, scientific approach is a matter of course for you
- SAP knowledge
- You appreciate independent and responsible work in a diverse product and project environment
On behalf of our client, a global leader within the Pharmaceutical Industry, Swisslinx is currently looking for a Quality Engineer to join a one year contract with a possible extension in Zug-area.
Your responsibilities:
- Create, update, review and training of specification documents, instructions and reports as well as technical review of validation and qualification documents
- Processing and technical review of deviations as well as technical approval of the assigned products
- Support quality management and ensure that regulated activities are carried out efficiently, effectively and in accordance
- Support in troubleshooting the assigned analysis system in the event of complex deviation reports
- Identification and presentation of improvement measures and implementation in consultation with the product team
- Interface between R&D, assembly, system testing and QA in order to find constructive solutions in the event of deviations and achieve a smooth approval
- Develop and maintain quality standards and metrics for key activities
- Mainly responsible for the deviation management of one or more products
- Responsible for the evaluation and analysis of quality data (e.g. right first time, deviation reports) as well as the management of corresponding meetings in the product team
Your background:
- Technical education with at least 2 years of professional experience in the medical technology field
- In-depth IT knowledge and understanding of complex hardware and software architectures (MS Office, Tableau)
- Experience in the regulated GxP environment, ideally medical technology (ISO 13485, GMP, FDA 21 CFR 820) in the area of ??deviation management
- Experience in deviation management of at least 2 years
- Mother tongue German or a comparable level (no exceptions)
- Fluent written English skills
Nice to haves:
- You have a pronounced quality awareness and a structured, scientific approach is a matter of course for you
- SAP knowledge
- You appreciate independent and responsible work in a diverse product and project environment
I manage this role